On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab).  This approval enables Celltrion to launch two additional autoinjector formulations (45mg/0.5mL and 90mg/1.0mL) in Canada.

Canada has seen significant biosimilar activity for ustekinumab.  The following products have already been approved by Health Canada:

The US market has seen an even bigger wave of ustekinumab biosimilar activity in 2025.  By the end of the year, the FDA had approved a total of eight ustekinumab biosimilars.  The following biosimilars launched in the US during 2025:

On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval from Health Canada.

Imuldosa® has already been launched in 19 countries, including the UK and Ireland (April 2025) and the US (August 2025).  It has also obtained marketing approval in the Middle East and North Africa region, including Saudi Arabia, Qatar, and the United Arab Emirates.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.  Intas is commercialising Imuldosa® through its global affiliates, including Accord BioPharma in the US and Accord Healthcare in Europe, the UK, and Canada.

A number of ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024), Fresenius’ Otulfi® (approved December 2024, launched May 2025) and Biocon’s Yesintek™ (approved October 2025).

On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Canada, Japan (approved January 2025), Europe (approved February 2025) and the United Kingdom (approved May 2025) from an unknown date.  Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.

A number of other ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024, not yet launched) and Fresenius’ Otulfi® (approved December 2024, launched May 2025).

On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The biosimilar is available in both IV and subcutaneous injection presentations to treat adults with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

FYB202/Otulfi® was developed by Formycon and was approved in Canada and the UK in January 2025 and in the US and Europe in September 2024.  It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025).  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

This closely follows the Canadian approval of both subcutaneous and intravenous formulations of FYB202/Otulfi® on 8 January 2025, for the same indications.

FYB202/Otulfi® was approved in Europe and the US in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In March 2024, Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202/Otulfi® in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2025”.  The agreed launch dates for FYB202 in the UK and Canada remain confidential.

We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleged that Janssen had abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”.  JAMP’s application was the first leave application under the Competition Act’s abuse of dominance provisions to be determined by the Tribunal since the 2022 amendments allowed private parties to seek leave to bring such applications.

On 20 November 2024, the Canadian Competition Tribunal dismissed JAMP’s application for leave to bring an action under the Competition Act.  The Tribunal held that JAMP’s complaint failed due to a lack of “cogent” evidence to support its allegations that:

• Janssen had gamed the regulatory system and engaged in “sham” litigation;
• Janssen’s FINLIUS drug was a “fighting brand” as JAMP had presented no argument to suggest that it was forced out of the market by FINLIUS;
• Janssen had engaged in predatory pricing;
• Janssen had sent anti-competitive communications to physicians, insurers and patients; and
• Janssen’s conduct could have the effect of substantially lessening or preventing competition in the ustekinumab market.

In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  The Alvotech-developed Jamteki^™ was approved by Health Canada in November 2023.  The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab.

On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings.  Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.  

Samsung commenced the impeachment proceedings as an interested person, on the basis that it had filed a submission for a notice of compliance (NOC) for Pyzchiva®, biosimilar to Stelara® (ustekinumab).  Samsung received an NOC for Pyzchiva® in August 2024.  At that time, Health Canada published a product monograph for Pyzchiva®, which listed Sandoz as a distributor of Pyzchiva®. 

The Federal Court dismissed Janssen’s motion to add an infringement counterclaim because it was not satisfied that the proposed pleading was adequately particularised, and considered that it did not disclose a reasonable cause of action.  The Court stated that, “considering the allegations of direct and induced infringement, both individually and collectively, it is apparent that Janssen does not know what Samsung and Sandoz are presently doing with Pyzchiva beyond obtaining regulatory approval, but is hoping to use the discovery process to find out.  This is not a proper pleading”. 

Ahead of Samsung Bioepis and Sandoz in Canada with ustekinumab biosimilars are: JAMP who launched the Alvotech developed first biosimilar Jameteki™ on 1 March 2024, Amgen who launched Wezlana™ on 4 March 2024 and Celltrion who reported on 31 July 2024 its Canadian approval for Steqeyma (CT-P43).  Biocon has also submitted a Canadian regulatory application, following a signed patent settlement and licence agreement with Janssen which enables Biocon to commercialise its ustekinumab biosimilar “Bmab 1200” in Europe, the United Kingdom, Canada and Japan. 

On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan. Biocon has submitted regulatory applications in each of these jurisdictions.

The Biocon-Janssen patent settlement and licence agreement follows the US settlement agreement in February 2024 enabling Biocon to launch Bmab 1200 in the US in February 2025.  In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.

Biocon reported in August 2024 year-on-year consolidated revenue growth of 30% for Q2 2024, with its biosimilars business delivering year-on-year growth of 11% compared with the same quarter last year.

JAMP recently filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleges that Janssen has abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”.

If JAMP succeeds in its leave application, it intends to seek a range of orders designed to curb Janssen’s alleged anti-competitive conduct as well as an order for a monetary penalty 3 times the value of the benefit which Janssen has derived from alleged anti-competitive conduct, estimated by JAMP to be at least $1 trillion.

In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. The Alvotech-developed Jamteki^™ was approved by Health Canada in November 2023. The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab.

On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

The Health Canada approval follows EMA’s recommendation for European marketing authorisation for Steqeyma and Celltrion’s earlier approval for Steqeyma in Korea on 12 June 2024.  Celltrion is also seeking approval for Steqeyma in the United States and Australia, submitting applications with FDA in June 2023, and TGA in April 2023.